A Study of RO5267683 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: placebo; Drug: RO5267683

• Registration Number: NCT01398241
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Healthy male and female subjects, 18 to 45 years of age,
• Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
• Female subjects must be surgically sterile or post-menopausal
• Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

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Exclusion Criteria

• History or evidence of any clinically significant disease or disorder
• Administration of an investigational drug or device within 3 months prior to dosing on Day 1
• Positive for hepatitis B, hepatitis C or HIV at screening
• Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Active	RO5267683	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	14 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid levels in the blood	14 weeks
Pharmacokinetics: Plasma concentrations	14 weeks
Pharmacokinetics: Urine concentrations	4 weeks